False-Negative Results in HPV Testing

WASHINGTON, DC (WUSA)-- Thousands of women are diagnosed with cervical cancer every year.

Tamika Felder got the shocking news at age 25. She is now twelve years out from that diagnosis. The cancer has not come back, but her treatment involved chemotherapy, radiation, and the surgical removal of her uterus, or womb.

"It changed my life forever," she says. "When I was diagnosed with cervical cancer, this was before HPV vaccines. No one was really talking about it." Felder has since formed an organization, Tamika & Friends, to make more women aware.

HPV or human papillomavirus is sexually transmitted. It usually doesn't cause symptoms, but it can lead to cervical cancer. There's now a vaccine called Gardasil that adolescents can get. And women can be screened for HPV when they get a Pap test at the gynecologist.

"The test should be an FDA approved test," says Bob Ortega, investigative reporter with the Arizona Republic. An article published in that newspaper this week focuses on SurePath, a test approved for Pap tests, but not screening for HPV.

This June, a bulletin from the FDA and SurePath's maker Becton Dickinson warned laboratories using the test that there's a danger of false-negatives. That is, women who have been infected with the HPV virus might be told they are not. Ortega say that warning never made it much further than the labs.

Ortega told WUSA 9 via satellite: "As a result, the gynecologists, the ones that were giving the tests never found out about it. I talked to gynecologists all over the country, I talked to the leading gynecological associations and none of them were familiar with this issue even 5 and 6 months after the FDA and Becton Dickinson had issued their bulletin."

Ortega continues: "There are two issues here. The first is that obviously if you get something that tells you you are free of HPV, when in fact you aren't, then you might not get treatment that you would need."

The other issue, Ortega says, are the new screening guidelines. Last year, the US Preventative Services Task Force told women they don't need to get a pap test yearly, as long as they don't have HPV. The group says its safe to wait five years. But Felder and other womens' health advocates disagree, especially if a patient gets a false-negative that could allow suspicious cells to multiply and grow.

She says, "It's dangerous telling women to wait every 5 years because I think many women will wait longer unless there is a problem."

Ortega says the take-home message from his investigation is this: women need to ask their gynecologists what HPV test is being done, and to ensure that its one of FOUR that are FDA approved.